TWI626968B - Medicament delivery device - Google Patents

Abstract

The medicine delivery device of the present invention includes a housing and a driving unit (24, 26, 28). The driving unit includes: an actuating element (52); the actuating element (52) is operably configured to fit in the housing (10) Medial movement for discharging a dose of medicine; the medicine delivery device further includes: a monitoring unit (30); the monitoring unit (30) is detachably attached to the housing; at least one sensor (32, 54), Configured in the monitoring unit (30), the at least one sensor (32, 54) is operatively configured to monitor the drive unit (24, 26, 28) for obtaining information about the drug delivery device Status information.

Description

Drug delivery device

The invention relates to a device for sensing the forces that occur during the operation of a drug delivery device.

There is an ever-increasing need to obtain information from the different devices and equipment we use daily, and drug delivery devices are no exception to this need. In this way, many drug delivery devices have been developed that contain "smart" components, such as sensors and monitoring systems, communication circuits, and human-machine interfaces that can present information about the status of the drug delivery device, for example.

Even if the cost of these smart components is decreasing, they are still too expensive, for example, to provide a disposable, smart drug delivery device. Another factor is that these discarded drug delivery devices will also contain discarded components. Recycling will be far better than discarding. If used up, the drug delivery device will be equipped with an intelligent circuit.

Another disadvantage is that if the drug delivery device is approved by the National Drug Administration and launched on the market if it is provided with increased functionality built into the drug delivery device. This will then require a new approval from the National Drug Administration Yes, it can take many years to obtain. If the increased functionality can be configured outside the drug delivery device and not built into them, it will be a better and simpler solution.

A particular feature of the drug delivery device of particular interest is, for example, monitoring the movement of components or elements of the drive unit, such as the plunger rod, which is acting on the drug container during the delivery of a dose of drug. However, since these components are arranged inside the housing of the drug delivery device without substantial modification, access to them can be difficult.

Patent document EP 2190506 discloses a drug delivery device equipped with a monitoring unit. In one embodiment, the electronic unit is configured as an attachable auxiliary device provided with a reader of an RFID sensor. One such RFID sensor is included in a sensor system that is placed inside the drug delivery device. As such, this solution requires modification or insertion of additional components inside the drug delivery device in order to obtain a higher degree of wisdom.

In this application, the term "distal part / end" means the part / end of the device, or the part / end of its component, which is located under the use of the device The delivery site farthest from the patient. Correspondingly, the term "proximal part / end" means the part / end of the device, or the part / end of the member, which is located closest to the patient under the use of the device Delivery site.

In the following description, the term smart device will be used. In this regard, the smart device may include an electronic device, which is provided with a computer capable of running The processor of the program, as well as the storage space for storing the program and the data retrieved from different external sources. Furthermore, it is understood that these smart devices are provided with a communication system capable of communicating with the data network in order to access different databases. It is understood that these databases can be accessed via the Internet, so-called cloud services, and / or databases that are directly connected to and accessed through the local area network. Furthermore, it is understood that regarding this point, the smart device includes a certain human-machine interface for two-way communication. The human-machine interface may include a display, a keyboard, a microphone, a speaker, and I / O ports for peripheral connections. Furthermore, the smart device may be provided with an antenna for wireless communication with such networks. The smart device may also be configured with receiving and transmitting mechanisms capable of communicating with short-range wireless communication circuits, and programs capable of establishing and processing communication with these circuits.

Furthermore, in the following description, the term drug delivery device will be used. In this regard, drug delivery devices may for example include many devices capable of delivering certain drug doses to the user, such as injection devices with or without injection needles, all types of inhalers, such as powders with mouthpieces or nosepieces, Smoke drive, gas, nebulizer, dispenser for medicine in tablet form, eye dispenser, etc. The drug delivery device may be of a disposable type or a type that can be reused, and may be a drug container provided with a specific medicine appropriately configured for a specific form in a specific form.

The object of the present invention is to remedy the shortcomings of these cutting-edge technology devices. This goal was obtained with the characteristic drug delivery device according to the independent item of the patent application. The preferred embodiments of the present invention form the subject of these patent-appendages.

According to a main aspect of the present invention, it includes a drug delivery device and a housing provided with a drive unit. The driving unit may contain a driving force element; the driving force element may be configured to act on an actuating element, such as a plunger rod. The plunger rod may be configured in order to act on the plug of the drug container disposed in the housing.

The drug delivery device may additionally include a monitoring unit, where the monitoring unit is detachably attached to the housing. Furthermore, at least one sensor may be configured in the monitoring unit, where the at least one sensor is operatively configured to monitor the drive unit for obtaining information about the state of the drug delivery device.

With this solution, the drug delivery device does not need to be modified in any major way in order to obtain a monitoring function. Since the monitoring unit can also be separated, it can be moved between different drug delivery devices. In this way, the disposable drug delivery device can also be configured with monitoring functions, which can be reused multiple times by attaching the monitoring unit to different devices and separating them from different devices. The disposable drug delivery device is then discarded.

According to one aspect of the invention, the at least one sensor may further include a force sensor configured to monitor the force from the driving force element. In that respect, the drug delivery device may additionally include a transmission element operatively connected to the driving force element for transmitting the force from the driving force element to the force sensor of the monitoring unit.

Since the force level is very clear to be measured by, for example, a pressure driving amount sensing element, the measurement of the force from the driving force element is an advantage. In order to be able to obtain information about the force from the driving force element, the drug delivery device may be configured with a transfer element that can transfer the force to the outside from the inside of the housing.

As another alternative solution, the at least one sensor may include an optical sensor configured to monitor the movement of the plunger rod. In this regard, the housing can be configured with an opening through which the optical sensor can monitor the movement of the plunger rod. The advantage of having an optical sensor is that the movement can be easily measured and is a well-proven technology, such as optical mouse technology. Furthermore, for monitoring the inside of the drug delivery device, no internal mechanical elements are needed, and the opening is all that is needed to allow light from the optical sensor to enter the interior and be reflected back.

According to an advantageous solution, the monitoring unit may additionally include a communication element for providing information to an external receiver. In this regard, the external receiver may be a user of the drug delivery device, where the user may be provided with information about the state of the drug delivery device. This information can be, for example, that the injection sequence has started and / or that the injection sequence has ended and it is safe for the dose delivery section to be moved to the drug delivery device. Furthermore, in this respect, the communication element may include means for providing visual, auditory and / or tactile information.

In addition, or as an alternative, the communication element may include circuits for short-range wireless communication, such as NFC-, RFID-, ANT-, Zigbee- or Bluetooth technology. This provides the possibility to carry and transmit information to, for example, a smart device, where the interface of the smart device can also be used to provide user or other people with status information of the drug delivery device.

These and other aspects and advantages of the present invention will be determined by the The following detailed description and the drawings become apparent.

10‧‧‧Housing

12‧‧‧Transmission components

14‧‧‧Disc body

16‧‧‧recess

18‧‧‧distal end wall

20‧‧‧bolt

22‧‧‧channel

24‧‧‧Drive spring

26‧‧‧Support plate

28‧‧‧Spring guide

29‧‧‧ Plunger rod

30‧‧‧Monitoring unit

31‧‧‧Housing

32‧‧‧Strength sensor

34‧‧‧Electronic circuit

36‧‧‧Button battery

38‧‧‧Communication components

40‧‧‧User interface

50‧‧‧ opening

52‧‧‧ Plunger rod

54‧‧‧Optical sensor

56‧‧‧beam

60‧‧‧Plane scroll spring

62‧‧‧Drive components

64‧‧‧Drive nut

66‧‧‧channel

68‧‧‧Thread

70‧‧‧Thread

72‧‧‧ Plunger rod

74‧‧‧Support surface

76‧‧‧support wall

78‧‧‧Frame

80‧‧‧sensor

82‧‧‧channel

84‧‧‧bolt

In the following detailed description of the present invention, reference will be made to the attached drawings, where FIG. 1 is a schematic view of a drug delivery device according to an embodiment; FIG. 2 is a schematic view of a drug delivery device with a monitoring unit attached to FIG. 1 Figure 3 is another alternative embodiment of a monitoring unit configured to a drug delivery device; and Figures 4-8 show another embodiment of a drug delivery device configured with a monitoring unit.

Devices capable of sensing the force on the components inside the drug delivery device are shown in these figures. The drug delivery device is preferably a disposable device that is discarded after use. The drug delivery device includes a housing 10 in which a delivery element 12 is configured. The delivery element 12 is operatively connected to the components and serves as the drug delivery device. In the illustrated embodiment, the transfer element 12 has a substantially disc-shaped body 14 configured to be movable in the longitudinal direction in the recess 16 in the distal end wall surface 18 of the housing 10. The distal guide surface of the disc-shaped body 14 of the conveying element 12 is configured with a pin 20 or the like protruding portion, which is positioned in the channel 22 in the distal end wall surface 18, thereby acting as the conveying element 12 in its most distal position, the pin 20 is outside the end wall 18 Extend a distance.

The drive unit may preferably be configured in the drug delivery device. The drive unit may contain a drive force element, such as a drive spring 24, which may be an injection sequential drive spring 24, with a distal end acting on the proximal surface of the disc-shaped body 14 of the transfer element 12. As seen in this embodiment, the drive spring 24 is acting on the transfer via a support plate 26 that is attached to or integral with the distal end of the spring guide 28 Element 12. In this regard, it will be understood that the transfer element may be integrated with the supporting disk, wherein the disk-shaped body 14 is the same component as the supporting disk 26.

As such, when the drug delivery device is ready for use, the drive spring 24 is tensioned and the delivery element 12 is forced to its most distal position with the peg 20 extending a distance outside the end wall 18. The proximal end of the drive spring is preferably operatively connected to an actuating element, such as a plunger rod 29, which can sequentially act on the plug of the drug container so that when the drive spring is activated, the plunger The rod system moves in the proximal direction and the stopper moves with it, thus performing a sequence of dose delivery.

In order to obtain information about the use of the drug delivery device, looking at FIG. 2, the monitoring unit 30 is configured to the drug delivery device. In the illustrated embodiment, the monitoring unit 30 is designed as an attachable unit with a housing 31 that can be releasably attached to the distal end of the drug delivery device. For this purpose, the monitoring unit 30 and the drug delivery device are equipped with suitable attachment elements (not shown), which can for example have many designs and configurations, such as threads, bayonet coupling, Embedded accessories, etc.

The monitoring unit 30 is configured with a force sensor 32 that is placed such that when the monitoring unit 30 is attached to the drug delivery device, it is in contact with the latch 20 of the delivery element 12, as shown in FIG. 2 Seen in the. In this regard, the force sensor 32 may be, for example, a design such as a piezoresistor or strain gauge that can convert a mechanical force applied to the force sensor 32 to an electrical signal or pulse. Furthermore, the monitoring unit 30 may be preferably equipped with an electronic circuit 34, and the force sensor 32 may be operatively connected to the electronic circuit. In order to operate the electronic circuit 34, a suitable power source may be configured, such as a button battery 36 and the like.

Furthermore, the monitoring unit 30 may be configured with a suitable communication element 38 for providing information to users or other people who need information about the status of a particular drug delivery device. In the basic embodiment, the monitoring unit 30 is configured with a communication element in the form of a user interface 40, which may include a visual display and / or a light source and / or a speaker and / or a tactile information provider, such as a vibration element.

In another embodiment, the communication element of the monitoring unit may include a certain wireless communication function, such as a short-range wireless communication technology integrated in the electronic circuit. These can be, for example, NFC-tags, RFID tags, Ant-circuits, Zigbee-circuits, which can transmit information to an external receiver over a short distance. For example, if an NFC-tag is used, the monitoring unit can be operably connected to a smart device, which is NFC-enabled. When this smart device is held close to the monitoring unit, the NFC-tag can be powered on and made to transmit information to the smart device.

Another type of technology that can be used is Bluetooth. A large number of devices can Communicate with each other via Bluetooth technology, and an advantage is that the drug delivery device with the monitoring unit does not need to be very close to the receiver, such as a smart device.

As mentioned above, the monitoring unit is equipped with a force sensor. The force sensor can measure the force from the driving spring via the transmission element. As such, when, for example, the injection sequence is initiated by the user of the drug delivery device, the force of the drive spring will move a plug inside the drug container, whereby a dose of drug passes through the drug delivery member attached to the drug container Conveyed. The movement of the plug by the drive spring will cause the drive spring to extend in the longitudinal direction, whereby the power that it can deliver is gradually reduced. Changes in the force output by the drive spring are sensed by the force sensor, which can be used as information about changes or progress in the state of operation of the drug delivery device.

For example, when the force sensor detects a force falling below a certain threshold, it can trigger a signal to the electronic component. Furthermore, when the plunger rod starts to move from a fixed state, the sensor can detect when the force begins to decrease, indicating the beginning of a dose delivery sequence. If the force sensor also detects that the reduction in force from the drive spring has ended, at the end of the dose delivery operation, it can trigger a signal to the electronic component due to the stop of the stopper. The electronic component can then be programmed so that it will warn the user that the drug delivery device is safe to move from the dose delivery portion. Further information that the sensor can provide during the entire dose delivery sequence is the entire force curve. This force curve can be compared to the pretest and the force curve of the commonly used drug container to detect possible injection problems of the drug delivery device, such as siliconization problems or incomplete injections, For example, due to internal friction of the drug container that exceeds the available spring force. The force curve can also indicate whether the injection operation was replaced in the tissue and caused in the air, resulting in a different force curve.

In another embodiment, the disk-shaped body 14 of the transmission element 12 may be configured within the housing 31 of the monitoring unit 30.

Figure 3 reveals a variant of the invention. Here the drug delivery device is configured with an opening 50, for example to provide access to the interior of the drug delivery device and to components that are moving during operation of the drug delivery device, such as the plunger rod 52, which is borrowed during the dose delivery operation For example, a drive spring moves in this longitudinal direction and acts on the stopper of the medicine container for delivering a dose of medicine.

In this embodiment, the monitoring unit 30 may be configured with an optical sensor 54 that can provide a reflected light beam 56 to detect the movement of components such as the plunger rod 52 of the drug delivery device, which Moving during the dose delivery sequence. In this regard, the motion component can be configured with a suitable type to facilitate motion detection. The optical sensor 54 can be operatively connected to the electronic circuit 34 as described above. In the same manner as above, the optical sensor can register the start of the movement, indicating, for example, the start of the dose delivery sequence and the stop of the movement, indicating the stop of the dose delivery sequence. Furthermore, the rate of movement during the dose delivery sequence can be monitored and compared to the motion pattern of the pre-tested and normally functioning drug container for detecting possible injection problems of the drug delivery device.

4 to 8 show another example of a drug delivery device that can be configured with a monitoring unit 30. In this embodiment, the drug delivery device is configured with a planar scroll spring 60 wound around the drive element 62, so that an outer end is attached to the housing portion (not shown). The drive element 62 is operably connected It is connected to a driving nut 64 provided with a central channel 66 having a thread 68. These threads 68 are configured to mate with threads 70 on the outer surface of the elongated plunger rod 72. The drive nut 64 is additionally provided with a support surface 74 directed distally, see FIG. 7, which is in contact with the proximal guide support wall surface 76 of the frame 78 of the drug delivery device, see FIG. 5. During use, the coil spring 60 will rotate the drive element 62 and thus the drive nut 64. The rotation of the drive nut 64 will cause the plunger rod 72 to move in the proximal direction and act on the drug container for discharging a dose of drug. The action of the driving nut 64 on the plunger rod 72 will cause the driving nut 64 to be pressed against the support wall 76 with a certain force.

According to the invention, the monitoring unit 30 may be configured to the drug delivery device, the monitoring unit being operatively connected to the sensor 80, see FIG. 4. In the illustrated embodiment, the sensor 80 is a force sensor capable of sensing the force from the driving nut 64. In this case, the channel 82 is arranged in the supporting wall surface 76, see FIG. 5. Furthermore, the driving nut 64 is provided with a bolt 84 that is guided distally, and extends in the channel 82 of the support wall surface 76. The force sensor 80 is disposed on opposite sides of the support wall 76 so that the distal end of the pin 84 is in contact with the force sensor 80.

It will be understood that the embodiments described above and shown in the drawings will only be regarded as non-limiting examples of the invention, and that they can be modified in many ways within the scope of such patent applications.

Claims (11)

A drug delivery device, comprising: a housing (10), a driving unit (24, 26, 28, 60), the driving unit includes: an actuating element (29; 52; 72); the actuating element (29; 52; 72) Operablely configured to move inside the casing (10) for discharging a dose of medicine; the driving force element (24, 60) acts on the actuating element (29; 52; 72); the medicine delivery device Contains: a monitoring unit (30); the monitoring unit (30) is detachably attached to the housing (10); at least one sensor (32, 54, 80) is configured in the monitoring unit (30) , The at least one sensor (32, 54, 80) is operably configured to monitor the drive unit (24, 26, 28, 60) for obtaining information about the state of the drug delivery device; transmission element (12; 84), operatively connected to the driving force element (24; 60) for transmitting the force from the driving force element (24) to the force sensor (32) of the monitoring unit (30) ), Wherein the at least one sensor includes a force sensor (32; 80), which is configured to monitor the force from the driving force element (24; 60). For example, the drug delivery device according to item 1 of the patent application scope further includes a spring guide rod (28) having a supporting disk (26), and the driving force element (24) is supported on the supporting disk (26). A drug delivery device as claimed in item 2 of the patent application, wherein the delivery element (12) is a substantially disc-shaped body (14) including a protruding portion (20). A drug delivery device as in claim 3, wherein the delivery element (12) is configured to be movable in a recess (16) in the distal end wall surface (18) of the housing (10) in the longitudinal direction , And wherein the protruding portion (20) is arranged in the channel (22) in the distal end wall surface (18), and thus the protruding portion (20) is constructed as the transmission element (12) is In its most distal position, it extends a distance outside the end wall (18). A drug delivery device as claimed in item 1 of the patent application, wherein the at least one sensor includes an optical sensor (54) configured to monitor the movement of the actuating element (52). For example, in the medicine delivery device of claim 5, the housing is configured with an opening (50), and the optical sensor (54) can monitor the movement of the actuating element (52) through the opening. For example, the drug delivery device according to any one of claims 1 to 6, wherein the monitoring unit (30) further includes a communication element (38) for providing information to an external receiver. For example, the drug delivery device of claim 7, wherein the communication element (38) includes means for providing visual, auditory and / or tactile information. For example, in the drug delivery device of claim 7, the communication element includes a circuit for short-range wireless communication. For example, the drug delivery device according to item 9 of the patent application, wherein the short-range wireless communication includes NFC-, RFID-, ANT-, Zigbee- or Bluetooth (Bluetooth) technology. A monitoring unit comprising a transmission element (12; 84) and at least one sensor (32); the transmission element (12; 84) is operably connected to the driving force of a driving unit provided inside the casing of the drug delivery device Element (24; 60); the at least one sensor (32) is operably configured to monitor the drive unit; the transmission element (12; 84) transmits the force from the driving force element (24) to the sensor A detector (32) for generating information about the state of the drug delivery device, the monitoring unit is detachably attached to the housing.